Bupivacaine vs Placebo for Unilateral Mastectomy Surgical Site Post-operative Pain Control

Breast Cancer Clinical Trial

Official title:

Double Blind, Randomized, Placebo Controlled Trial of Locally Instilled Bupivacaine in the Surgical Bed After Unilateral Mastectomy Without Reconstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03351348
• Other study ID #: 17-576
• Status: Recruiting
• Phase: Phase 3
• Start date: November 16, 2017
• Est. completion date: November 2026

Study information

• Verified date: December 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Laurie Kirstein, MD
• Phone: 848-225-6121
• Email: kirsteil[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare using FDA-approved bupivacaine (a numbing medicine), along with the usual medications for post-operative pain control to using the usual medications for postoperative pain control alone. The addition of bupivacaine to the surgical wound site with the usual pain medications could better manage your pain immediately after surgery and reduce the amount of opioid medications taken after surgery. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: November 2026
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Females = 18 years of age
• Patients undergoing unilateral mastectomy with or without SLNB or axillary dissection
• Patients scheduled for surgery at the JRSC or MSK Monmouth
• Previously enrolled patients > 6 months from contralateral mastectomy

Exclusion Criteria:

• Male breast cancer patients
• Patients who are non-English speaking
• Patients having any immediate breast reconstructive procedure
• Patients are having bilateral mastectomy
• Patients who report a baseline pain score > 3, unrelated to a breast procedure
• Patients who take long acting opioid medication use
• Patients will be excluded if they are having their mastectomy performed with tumescence
• Patients weighing < 40kg as 20cc of bupivacaine 0.5% is greater than the maximum allowed dose
• Patients within 6 months of previous enrollment for surgery for contralateral mastectomy

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Drug:
• Bupivacaine
The intervention in this study is the insertion of 20cc of 0.5% bupivacaine via a drain into the mastectomy wound for 2 hours ± 30 minutes postoperatively in patients undergoing unilateral mastectomy without breast reconstruction +/- SLNB, +/- axillary dissection.

Behavioral:
• patient-reported pain scores
Will be recorded by the nurse in the PACU as per usual practice. Patients will be given a follow-up Brief Pain Inventory (short form) 6 months and 1 year after surgery to assess their level of chronic pain. Patients may be discharged when table either on the day of surgery or post-operative day 1 (on pill diary for same-day discharge patients).

Other:
• saline
The intervention in this study is the insertion of 20cc of saline via a drain into the mastectomy wound for 2 ± 30 minutes hours postoperatively in patients undergoing unilateral mastectomy without breast reconstruction +/- SLNB, +/- axillary dissection.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (Consent and follow-up only)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Commack (Consent and follow-up only)	Commack	New York
United States	Memorial Sloan Kettering Westchester (Consent and follow-up only)	Harrison	New York
United States	Memorial Sloan Kettering Monmouth (All Protocol Activities)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering Nassau (Consent and follow-up only)	Uniondale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients that have moderate to severe pain	Validated measures consisting of the Comparative Pain Scale and Simplified Postoperative Nausea and Vomiting (PONV) impact scale are currently administered to postoperative patients at JRSC. The Comparative pain scale ranges from 0-10, with 0 representing no pain and 10 representing the most severe pain.; 0 = no pain 1-3 = minor pain 4-6 = moderate pain 7-10 = severe pain	up to 24 hours

External Links

•   Memorial Sloan Kettering Cancer Center